Levetiracetam Use in Neonates: Saftey, Tolerability, and Long Term Outcome
Abstract number :
2.198
Submission category :
Antiepileptic Drugs-Pediatrics
Year :
2006
Submission ID :
6637
Source :
www.aesnet.org
Presentation date :
12/1/2006 12:00:00 AM
Published date :
Nov 30, 2006, 06:00 AM
Authors :
1Beverly S. Wical, 2Frank J. Ritter, and 1Shani K. Norberg
Neonatal seizures continue to lack therapies with proven efficacy and safety. Up to 50% of neonatal seizures are not controlled despite treatment with phenobarbital (PB) or fosphenytoin (fPHT). Concerns about toxicity of antiepileptic drugs (AEDs) in this special population persist. Term infants who fail standard therapy require additional treatment. Levetiractam (LEV) is considered a safe medication, with no significant drug interactions and no known neurotoxicity. We present our experience with LEV in 19 full term newborns., Retrospective chart analysis was performed: we identified 19 term infants who received LEV in the first 28 days of life. Charts were reviewed for demographics, birth weight, gestational age, age of seizure onset, and day of life LEV started. We reviewed other treatments, etiology of seizures, EEG and MRI results. Initial LEV and maintenance doses were recorded. Adverse events and side effects were reviewed. Number of infants continuing on LEV, and number seizure free were identified., Nineteen infants with gestational ages 38 to 42 weeks receieved LEV for clinical seizures. LEV was administered by oral or nasogastric route. Seven infants were female, 12 male. Etiology for seizures included: cerebral infarction (6), unknown (4), hypoxia (2), congenital brain anomaly (2), extra-axial hemmorhage (2), mitochondrial disorder (1), bacterial meningitis (1), and prolonged hypoglycemia (1). All had EEG studies and MRI. Prior to starting LEV, 14 infants were treated with PB (level =/[gt] 30), fPHT (level =/[gt] 18), or both. One infant received a lower dose of PB; 4 received LEV as initial treatment. Doses of LEV given in the first 24 hr of treatment were 4 mg/kg to 42 mg/kg (mean 16 mg/kg). Maintenence doses ranged from 25 mg/kg/d to 90 mg/kg/d (mean 32 mg/kg/d). No infant had any significant adverse event related to LEV initiation or continued treatment. Transient initial sedation was noted in 3 infants. Prior to reaching optimal dosing, 2 infants discontinued LEV due to side effects. One was irritable, the other was sedated. Three infants stopped LEV due to lack of efficacy; all 3 failed multiple other medications. Fourteen of 19 infants continued LEV therapy beyond the neonatal period. Eleven became seizure free on LEV. Eight discontinued AEDs; 7 have been followed for 34 - 57 mo (mean 32 mo) and remain seizure free. Six infants continue on LEV with excellent seizure control; duration of follow up is 9 to 45 mo (mean 18 mo)., No significant adverse events were identified in this retrospective study of 19 term infants who received LEV. The majority (14/19) had difficult to treat seizures. It was well tolerated by 17/19 (90%) of infants. Fourteen of 19 (73%) received benefit from LEV therapy; 11/19 (58%) became seizure free. Our study suggests LEV is a promising therapy for neonatal seizures. Larger studies of safety and efficacy are needed.,
Antiepileptic Drugs